Active Bottle for Preterm Infant Oral Feeding

描述(由申请人提供)： 在2000年美国约400万活产婴儿中，11.6%或约471,000名婴儿出生时孕周不到37周(Martin等人)。早产儿可能会在新生儿重症监护病房(NICU)呆上几天或几个星期，在那里他们通过鼻胃喂养管获得营养支持，直到他们能够通过吸吮和吞咽的方式进行口服喂养，并能够消化母乳或配方奶粉(Schanler&Lau)。对于其他健康的早产儿来说，口腔喂养困难是延长重症监护时间的唯一最重要的决定因素(Eichenwald等人)。持续的口腔喂养问题可能导致严重的健康后果，包括营养不良和智力发育受损(Jones，Morgan&Shelton)。此外，据估计，在美国，新生儿重症监护的费用在每名患者50,000至100,000美元之间(Zupancic等人)。减少与口腔喂养困难相关的NICU天数可以大大降低这一成本和与喂养相关的健康问题的风险。 第二阶段将进行一项临床研究计划，以评估计算机控制的主动瓶装牛奶输送系统的安全性和概念验证，该系统在第一阶段期间在实验室开发和测试。该系统旨在促进呼吸与吸吮和吞咽的协调，并减少早产儿留在重症监护病房的天数。在波士顿儿童医院(CHB)和贝丝以色列女执事医疗中心(BIDMC)，Infvocitex的工程师将提供必要的主动瓶子系统，包括瓶子、电子设备和控制以及一次性组件，以进行临床研究。受试者将是在CHB和BIDMC的新生儿重症监护病房(NICU)接受护理的32名婴儿，他们在第一次测试中怀孕后32到34周，除了早产外都是健康的。此外，二期项目组将与照顾者合作，对主动瓶设计进行人为因素评估。

DESCRIPTION (provided by applicant): Of approximately 4 million live births in the U.S. in year 2000, 11.6 percent or about 471,000 infants were born less than 37 weeks gestation (Martin et al). Preterm infants may spend days or weeks in a neonatal intensive care unit (NICU), where they are nutritionally supported by nasogastric feeding tube, until they are capable of oral feeding by means of sucking and swallowing and can digest human milk or formula (Schanler & Lau). For otherwise healthy preterm infants, oral feeding difficulty is the single most important determinant of prolonged stays in intensive care (Eichenwald et al). Serious health consequences can result from persistent oral feeding problems, including malnutrition and impaired intellectual growth (Jones, Morgan & Shelton). Moreover, it is estimated that in the U.S., the cost of neonatal intensive care ranges between 50,000 and 100,000 dollars per patient (Zupancic et al). A reduction in number of NICU days associated with oral feeding difficulty could substantially reduce this cost and the risk of feeding-related health problems. The Phase II will undertake a clinical research program to evaluate both safety and proof-of-concept of a computer-controlled active bottle milk delivery system developed and tested in the laboratory during the Phase I. This system is designed to promote coordination of breathing with sucking and swallowing and to reduce the number of days that preterm infants remain in intensive care. Engineers at Infoscitex will provide the necessary active bottle systems, including bottles, electronics and control, and disposable components to conduct the clinical research at Children's Hospital Boston (CHB) and Beth Israel Deaconess Medical Center (BIDMC). Subjects will be 32 infants receiving care in the Neonatal Intensive Care Units (NICUs) at CHB and BIDMC, who are 32 to 34 weeks post conceptional age at the first test and are healthy except for their early birth. In addition, the Phase II project team will work with caregivers to conduct a human factors evaluation of the active bottle design.